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The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU.

The LimFlow V-Ceiver is a percutaneous snaring device with a luer on the proximal end and a snaring basket at the distal end. The basket is composed of nitinol for shape memory and visibility with radiopaque markers on either end of the basket for added visibility. The coaxial sheathing system is used to re-constrain the basket once a guide wire is captured.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance based on image analysis, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for the LimFlow V-Ceiver, which is an embolectomy catheter, a physical medical device. The clearance is based on demonstrating substantial equivalence to a predicate device (LimFlow V-Ceiver K222083) through non-clinical performance tests, biocompatibility, sterilization, and packaging validation.

The "Indications for Use" explicitly state: "The LimFlow V-Ceiver is intended for use in the cardiovascular system to manipulate and retrieve guidewires specified in the IFU." This indicates it's a device for physical manipulation within the body, not an imaging or AI-based diagnostic tool.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to image analysis.
2. Sample size, data provenance, number of experts, adjudication methods for a test set, MRMC studies, standalone performance, or ground truth types related to an AI/imaging device.
3. Information on training sets or their ground truth establishment for an AI/imaging device.

The provided text pertains to the regulatory clearance of a physical medical device.

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